CDE drug review weekly report (February 29, 2016 to March 6, 2016)

This week, two types of 1.1 chemicals developed by Shanghai Pharmaceutical Research Institute entered the evaluation stage, and fcn-411 capsule of Fosun Pharmaceutical and tq-b3234 capsule of Zhengda Tianqing were approved for clinical use In addition, Qilu pharmaceutical's first bionic analogue has also been approved for clinical use This week, 1 This week (2016.2.29-3.6), another 4 (calculated according to the acceptance number, the same below) 1.1 chemicals entered the review stage, involving 2 varieties, namely, gumetinib tablets of Shanghai Pharmaceutical Research Institute and mefurepiride hydrochloride tablets of Chenxin pharmaceutical 2 Fcn-411 capsule, a major special product of Chongqing fuchuang, a subsidiary of Fosun Pharmaceutical, was approved for clinical use only 4 months after entering the evaluation center 3 Wang Zhengda Tianqing, the clinical approval document of last week, was approved for the clinical application of tq-b3234 capsule, a new class 1.1 drug this week 4 Qilu pharmaceutical's first recombinant human thrombopoietin peptide Fc fusion protein for the injection of biological analogues was approved for clinical use 5 This week, 32 1.1-class chemicals have been certified and approved for clinical use, including al2846 capsules and al8326 tablets of adecheng, boxitinib capsules of dongyangguang, xccs605b for injection of Zhejiang medicine, hsk3486 emulsion injection of HISCO, etc., which were introduced in the previous weekly reports 6 There are 61 drugs in the review stage this week, with 6 categories accounting for half, but no imported drugs 7 The production applications of class 3.1 chemicals approved this week were withdrawn, and 88% (51 / 58) of class 6 chemicals were withdrawn Every week, there will be a play back to the story before liberation 8 This week, a total of 464 drugs have been certified, 432 of which have been approved for clinical use This week, the National Bureau really competed As more and more drugs have been approved for clinical use, the clinical approval documents will become more and more worthless, and the clinical application will become more and more difficult Key drugs: 1 Gumetinib tablet: This product is a c-met inhibitor developed by Shanghai Pharmaceutical Research Institute, and then transferred to Lvgu pharmaceutical This product is a sulfonamide structure compound, which has a great risk of renal crystallization, because when using sulfonamide drugs, you should drink more water and increase urination If the amount of drinking water is insufficient, the amount of urine is small, and the concentration of drugs in urine is high, sulfanilamide crystals are easily precipitated in the kidney The clinical application of this product is currently in the review stage, and it is expected to be approved 2 Mefurepiride hydrochloride tablets: This product was developed by Dr Miao Zehong of Shanghai Pharmaceutical Research Institute It is a PARP1 inhibitor, which is used to treat tumors Dr Miao has made two PARP1 inhibitors, the other one is siminperi He has only been in line for 4 months in the Evaluation Center for approval At present, the certificate has been prepared and approved for clinical use The clinical application of mefurepiride hydrochloride has just entered the evaluation center, and it is expected to be approved more quickly 3 Fcn-411 capsule: This product has been introduced in review weekly report 60 (click to view review weekly report 60) It was just entered the review center at that time, but now it has been reviewed There are two specifications of this product At present, one of them has been approved for clinical use It is believed that the other one has no problem, just a matter of time 4 Tq-b3234 capsule: This product is the third class 1.1 drug declared by Zhengda Tianqing since 2010 The first two are respectively enrotinib hydrochloride capsule and sulbutinib maleate capsule (here does not include tenofovir fumarate dipentyl ester) Tq-b3234 capsule entered the evaluation center in April 2015 It is a special approved variety At present, it has been reviewed and approved for clinical application The confidential information of this product is very well done The editor has spent a lot of effort to find no information A friend who knows can leave a message 5 Recombinant human thrombopoietin mimic peptide Fc fusion protein for injection: This product is a biological similar drug declared by Qilu Pharmaceutical Co., Ltd It is speculated that it is a generic drug of anjinlomistine The production process should be that the Fc fragment of immunoglobulin G combines with thrombopoietin mimic peptide to form fusion protein to prolong the half-life and make a long-term preparation This product is mainly used for the treatment of idiopathic thrombocytopenic purpura It entered the review center in November 2013 and has been reviewed and approved for clinical use.